CMC Regulatory Sciences Coordinator

Rensselaer, NY, United States
Jan 30, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible for coordinating and supporting the deliverables and continuous improvement projects of the CMC Regulatory Sciences department to ensure timelines are met, potential resource constraints are anticipated, and changes in the expectations of regulatory authorities are incorporated into the business.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Regulatory intelligence:

• Maintains electronic system for cataloguing and tracking regulatory agency information requests, responses, and commitments for all CMC-RS submissions.

• Prepares reports and metrics from the electronic system for cataloguing and tracking regulatory agency information requests and commitments.

• Program tracking:

• Tracks the due dates for Specialist deliverables to help identify resource constraints before they result in slipping timelines.

• Coordinates the initiation of regulatory submission document reviews (e.g., cross-functional reviews and copyediting/data verification reviews with the CMC RS Document Quality group.

• Provides submission coordination support:

• Initiates SharePoint workflows.

• Updates batch analysis tables as new lots are dispositioned.

• Formats submission sections (e.g., stability and batch analysis tables).

• With guidance/oversight of specialists, organizes the product SharePoint folders into a consistent scheme with improved navigability.

• Tracks ex-US commercial filings completed by partners.

• Creates/maintains content trackers for regulatory submissions for assigned programs.

• Keeps management and others informed on progress of CMC-RS deliverables for assigned programs.

• Department support:

• Prepares agendas and minutes for group and department meetings. Prepares group and department newsletters.

Education and Experience:

• BS/BA in a scientific discipline preferred.

• Project management experience preferred.

• Requires strong organizational skills - will need to do many things at once and keep tabs on multiple projects; strong verbal and written communication skills, and strong reporting skills, including fluency in MS Word and Excel.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.